jRCT2071210028招募中不适用
A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 主要终点
- proteinuria
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age and Sex
- •Male and female subjects aged 18 and older at the time of signing the ICF prior to
- •initiation of any study specific activities/procedures.
- •Types of Subjects and Disease Characteristics
- •Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary
- •Biopsy could have occurred at any point in time prior to study.
- •A diagnostic report must be available for review by the Sponsor or designee.
- •Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been
- •stable for at least 12 weeks prior to screening.
- •Investigator discretion should be used in determining maximally tolerated and
- •optimized dose.
- •Subjects who are intolerant to RAS inhibitors are eligible but will not exceed
- •~5% of total population randomized.
- •UPCR >= 1 g/g (>= 1000 mg/g) based on a central laboratory assessment of first morning
- •void urine collected at screening.
- •eGFR of at least 30 mL/min/1.73 m2 at screening based on the CKD-EPI equation.
- •Pregnancy and Contraception
- •Willing to abide with highly effective forms of contraception, as specified in the
- •protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal
- •contraceptive agents must have been started at least 1 month prior to baseline.
- •Informed Consent
- •Willing and able to provide written informed consent and comply with all study visits
- •and study procedures.
排除标准
- •5.2 EXCLUSION CRITERIA
- •Subjects must meet NONE of the following exclusion criteria to be enrolled.
- •Concurrent diagnosis of another cause of chronic kidney disease including diabetic
- •kidney disease or another primary glomerulopathy.
- •Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO
- •guidelines or clinical suspicion of Henoch-Schonlein Purpura.
- •Diagnosis of nephrotic syndrome with serum albumin < 3 g/dL at screening.
- •BNP value of > 200 pg/mL at screening.
- •Platelet count <80,000 per uL at screening.
- •History of organ transplantation (subjects with history of corneal transplant are not
- •Use of systemic immunosuppressant medications including mycophenolate,
- •azathioprine, cyclosporine, tacrolimus, etc.; use of herbs such as Tripterygium Wilfordii
- •Hook F, Caulis sinomenii and Sinomenium acutum; for > 2 weeks in the past 3 months.
- •Use of rituximab within the past 6 months.
- •Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean
- •of 3 measurements obtained at screening.
- •Known history of heart failure or prior hospital admissions for conditions relating to
- •fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural
- •effusion, or ascites.
- •Known history of clinically significant liver disease or transaminase or bilirubin values
- •more than twice the upper limit of normal. Subjects with treated hepatitis C can be
- •considered for inclusion into the study upon consultation with the Sponsor's Medical
- •Monitor (or designee).
- •Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia
- •within 3 months of screening.
- •History of malignancy unless cancer free for at least 5 years or nonmelanoma skin
- •cancer not requiring ongoing treatment. A subject with curatively treated cervical
- •carcinoma in situ is eligible for this study.
- •Pregnancy, breast feeding, or intent to become pregnant during the study period and at
- •least 1 month afterward for females.
- •Intent to father a child or donate sperm during the study period and at least 1 month
- •afterward for males.
- •Have received any investigational agent within 1 month (or 5 half-lives of the agent,
- •whichever is longer) prior to screening. If the investigational agent is a cytotoxic or
- •immunosuppressive agent then this washout period is 6 months.
- •Concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary,
- •hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation,
- •immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the
- •Investigator or Sponsor's Medical Monitor (or designee), might confound the results of
- •the study or pose additional risk to the subject by their participation in the study.
- •History of an alcohol or illicit drug-related disorder within the past 3 years.
结局指标
主要结局
proteinuria
时间窗: from baseline to Week 24
The change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection)
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infectiogenotype 1 chronic hepatitis CinfectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-021716-42-BESCS Boehringer Ingelheim Comm.V625
进行中（未招募）
不适用
A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infectiogenotype 1 chronic hepatitis CinfectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-021716-42-PTBoehringer Ingelheim International GmbH625
进行中（未招募）
1 期
A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infectioEUCTR2010-021716-42-GBBoehringer Ingelheim Limited778
进行中（未招募）
不适用
A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infectiogenotype 1 chronic hepatitis CinfectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-021716-42-DEBoehringer Ingelheim Pharma GmbH & Co. KG625
进行中（未招募）
不适用
A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-a and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infectioEUCTR2010-021716-42-ATBoehringer Ingelheim RCV GmbH625